![]() In clinical trials, the median decline in anti-factor Xa activity for apixaban or rivaroxaban was 88% or higher. The increase in available factor Xa reduces anticoagulant action, which can be measured by anti-factor Xa activity, thrombin generation, or unbound factor Xa inhibitor plasma concentration from baseline. Īndexanet alfa acts as a decoy and sequesters rivaroxaban or apixaban, inhibiting them from binding to natural factor Xa. The FDA also considered the interim results of an ongoing trial, ANNEXA-4, which analyzed reversal of apixaban, rivaroxaban, edoxaban, or enoxaparin in patients presenting with major acute bleeding within 18 hours of the last dose of a factor Xa inhibitor. These trials evaluated the efficacy and safety of andexanet alfa in reversing apixaban and rivaroxaban, respectively, in healthy volunteers. Īndexanet alfa received approval as a breakthrough therapy and as an orphan drug based on the results of two phase 3 trials, ANNEXA-A and ANNEXA-R. It does not currently have approval for the reversal of edoxaban, fondaparinux, or low-molecular-weight heparins due to a lack of sufficient data in patients on these agents. Andexanet alfa is the first FDA-approved reversal agent for factor Xa inhibitors. However, emergency room visits and hospital admissions for bleeding due to factor Xa inhibitors have risen with the increasing use of these agents. ![]() ![]() They are also convenient in that less routine blood monitoring is required than with the use of warfarin. įactor Xa inhibitors have demonstrated effectiveness as warfarin with a better safety profile in terms of bleeding. Andexanet alfa is a recombinant modified factor Xa protein approved by the FDA in May 2018 to reverse apixaban and rivaroxaban in patients with life-threatening or uncontrolled bleeding. ![]()
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